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Information about Iodoral from Optimox
PLEASE CONSULT YOUR PHYSICIAN BEFORE USE

- High
Potency Iodine/Potassium Iodide Supplement

One
tablet of Iodoral supplies an amount of total elemental iodine, comparable to
the average daily intake of this essential element by mainland Japanese, a
population with a very low prevalence of fibrocystic disease of the breast and
breast cancer.

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Iodine is an essential
element. Although its main function is in the production of thyroid hormones
by the thyroid gland, other organs in the body have a need for iodine in order
to function normally(*4).

Several studies have
demonstrated a relationship between low iodine intake and fibrocystic disease
of the breast (FDB), both in women and laboratory animals (*1,2). The minimum
amount of iodine required for control and prevention of FDB is equivalent to
0.1mg/kg body weight/day. For example, for a 50 kg woman, the daily amount of
iodine would be 5 mg. The thyroid gland needs iodide to function properly. The
original study done 80 years ago to control goiter in adolescent girls used 9
mg iodide daily (*3).

During the early
1900's, the iodine/iodide solution called Lugol solution was used extensively,
effectively and safely in medical practice, for both low activity and above
normal activity of the thyroid gland (*4). The recommended daily intake for
iodine supplementation was 2 to 6 drops of Lugol solution containing 12.5 to
37.5 mg total iodide. That amount was mentioned as lately as 1995 in a book on
Pharmaceutical Sciences (*5). Several investigators have shown convincing
evidence connecting inadequate iodine intake and breast cancer (*6). Japanese
women living in Japan consumed a daily average of 13.8 mg total elemental
iodine and they experience one of the lowest prevalence (risk) for breast,
ovarian and uterine cancer (*6). In the 1960's, one slice of bread in the USA
contained the full RDA of 0.15 mg iodine. The risk for breast cancer was then
1 in 20 (*7). Over the last 2 decades, iodine was replaced by bromine in the
bread making process. Bromine blocks thyroid function and may interfere with
the anticancer effect of iodine on the breast (*4). Now, the risk for breast
cancer is 1 in 8 and increasing 1% per year (*7).

The RDA limits for
vitamins and minerals were established after World War II. One of the last
essential elements included in the RDA system was iodine, established in 1980
and confirmed in 1989 (*8). The RDA for iodine was based on the amount of
iodine/iodide needed to prevent goiter, extreme stupidity and hypothyroidism
(*9). The optimal requirement of the whole human body for iodine has never
been studied. Therefore, the optimal amount of this element for physical and
mental wellbeing is unknown. Based on demographic studies, the mainland
Japanese consumed an average of 13.8 mg daily and they are one of the
healthiest people on planet earth (*6). Lugol solution is a time-tested
preparation with a proven track record for over 150 years. Two drops contain
12.5 mg iodine/iodide, an amount very close to the 13.8 mg average intake of
mainland Japanese.

II.
RATIONALE FOR THIS

FORMULATION

Administration
of iodine/iodide in liquid solution is not very accurate, may stain clothing,
has an unpleasant taste and causes gastric irritation. Iodoral®
is a precisely quantified tablet form
containing 5 mg iodine and 7.5 mg iodide as the potassium salt. To prevent
gastric irritation, the iodine/iodide preparation was absorbed unto a
colloidal silica excipient; and to eliminate the unpleasant taste of iodine,
the tablets were coated with a thin film of pharmaceutical glaze (*10).

III.
SUGGESTED USE

The suggested
daily amount is 1-4 tablets/day as recommended by your physician. Work closely
with your physician while on the Iodoral®
program. Report to your physician any
history of thyroid surgery and/or radiation, chronic lymphocytic thyroiditis
(Hashimoto), and any previous problem with your thyroid. Before starting
Iodoral®,
your physician (He/She = He) will order blood tests for hematology, blood
chemistry and thyroid functions. He will also perform an ultrasound of your
thyroid to measure the size and appearance of your thyroid. Depending on the
results of the thyroid function tests and ultrasound, he may order some blood
tests for thyroid antibodies. If you are taking thyroid hormones, let your
physician know about it. Be aware that Iodoral®
enhances the response of your body to
thyroid hormones (*4,6). Subjects on Iodoral®
feel warmer in cold environments and that
is expected. However, you will need to cut down the amount of thyroid hormones
if you experience palpitation, anxiety, increased sweating and intolerance to
heat. That is because Iodoral®
decreases your need for thyroid hormones.
Your physician will guide you in titrating downward the amount of thyroid
hormones. Your physician will reevaluate you one month afterward if you are on
thyroid hormones, and 3 months if not. Keep a record of what you observe while
on Iodoral®
and show it to your physician.

To test whole
body sufficiency for iodine, 4 tablets of Iodoral® are ingested, followed by
24 hr. urine collection. The more deficient a subject is in iodine, the more
iodine is retained by the body and the least excreted in the urine.
Sufficiency is achieved when 90% or more of the ingested amount is excreted in
the urine. In most subjects tested, 3-4 tablets of Iodoral®/day
were required to achieve whole body sufficiency within 3 months and the body
retained approximately 1.5 gm iodine at sufficiency (*4,8). The best response
in patients with FDB was observed with ingestion of 2 tablets twice a day
(*8). Check with your physician for more information about the loading test.